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AISight Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis. AISight Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. AISight DX is intended to be used with interoperable displays, scanners and file formats, and web browsers that have been 510(k) cleared for use with the AISight Dx or 510(k)-cleared displays, 510(k)-cleared scanners and file formats, and web browsers that have been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying interoperable devices.

AISight Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation, and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner or Leica Aperio GT 450 DX scanner (Table 1). It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.

For In Vitro Diagnostic Use The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.

The PathPresenter Clinical Viewer (version V1.0.1) is a web-based software application designed for viewing and managing whole slide images generated from scanned glass slides of formalin-fixed, paraffin-embedded (FFPE) surgical pathology tissue. It serves as a diagnostic aid, enabling pathologists to review digital images and render a primary pathology diagnosis. Functions of the viewer include zooming and panning the image, annotating the image, measuring distances and areas in the image and retrieving multiple images from the slide tray including prior cases and deprecated slides.

RadiForce MX317W-PA is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. RadiForce MX317W-PA is an aid to the pathologist and is used for review and interpretation of histopathology slides for the purposes of primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using this product. The display is not intended for use with digital images from frozen section, cytology, or non- formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

RadiForce MX317W-PA is a color LCD monitor for viewing digital images of histopathology slides. The color LCD panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size is 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve, a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced. "Patho" is for intended digital pathology use mode.

For In Vitro Diagnostic Use Only CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and the validity of the interpretation of images using CaloPix. CaloPix is intended to be used with the interoperable components specified in the below Table: | Scanner Hardware | Scanner Output File Format | Interoperable Displays | |---|---|---| | Leica Aperio GT 450 DX scanner | SVS | Dell U3223QE | | Hamamatsu NanoZoomer S360MD Slide scanner | NDPI | JVC Kenwood JD-C240BN01A |

CaloPix, version 6.1.0 IVDUS, is a web-based software-only device that is intended to aid pathology professionals in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed on the Dell U3223QE display. CaloPix does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis. CaloPix is for viewing digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. As a whole, CaloPix is a pathology Image Management System (IMS) which brings case-centric digital pathology image management, collaboration, and image processing. CaloPix consists of: - Integration with Laboratory Information Systems (LIS): Allows to obtain automatically from the LIS patient data associated with the cases, scanned whole slide images and other related medical images to be analyzed. The data stored in the database is automatically updated according to the interface protocol with the LIS. - DataBase: After ingestion, scanned WSI can be organized in the CaloPix database consisting of folders (cases) containing patient identification data and examination results from a LIS. Ingestion of the slides is performed through an integrated module that allows their automatic indexation based on patient data retrieved from the LIS. After their ingestion, image files are stored in a CaloPix-specific file storage environment, that can be on premises or in the cloud. - The CaloPix viewer component to process scanned whole slide images, that includes functions for panning, zooming, screen capture, annotations, distance and surface measurement, and image registration. This viewer relies on image servers (IMGSRV) which extract image tiles from the whole slide image file and send these tiles to the CaloPix viewer for smooth and fast viewing.

For In Vitro Diagnostic Use Viewer+ is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. Viewer+ is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Viewer+ is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner and BARCO MDPC-8127 display.

Viewer+, version 1.0.1, is a web-based software device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from Hamamatsu NanoZoomer S360MD Slide scanner and viewed on BARCO MDPC-8127 display. Viewer+ renders these digitized pathology images for review, management, and navigation for pathology primary diagnosis. Viewer+ is operated as follows: - 1. Image acquisition is performed using the NanoZoomer S360MD Slide scanner according to its Instructions for Use. The operator performs quality control of the digital slides per the instructions of the NanoZoomer and lab specifications to determine if re-scans are necessary. - 2. Once image acquisition is complete and the image becomes available in the scanner's database file system, a separate medical image communications software (not part of the device) automatically uploads the image and its corresponding metadata to persistent cloud storage. Image and data integrity checks are performed during the upload to ensure data accuracy. - 3. The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and areas, and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis.

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The PIPS 5.1 comprises the Imagement System (IMS) 4.2, Ultra Fast Scanner (UFS), Pathology Scanner SG20. Pathology Scanner SG60, Pathology Scanner SG300 and Philips PP27QHD display, a Beacon C411W display or a Barco MDCC-4430 display. The PIPS 5.1 is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS 5.1.

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. PIPS 5.1 consists of two subsystems and a display component: - 1. A scanner in any combination of the following scanner models - . Ultra Fast Scanner (UFS) - Pathology Scanner SG with different versions for varying slide capacity . Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 - 2. Image Management System (IMS) 4.2 - 3. Clinical display - PP27QHD or C411W or MDCC-4430 . PIPS 5.1 is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. The PIPS does not include any automated image analysis applications that would constitute computer aided detection or diagnosis. The pathologists only view the scanned images and utilize the image review manipulation software in the PIPS 5.1.

The Epredia E1000 Dx Digital Pathology Solution is an automated digital slide creation, viewing, and management system. The Epredia E1000 Dx Digital Pathology Solution is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Epredia E1000 Dx Digital Pathology Solution is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The Epredia E1000 Dx Digital Pathology Solution consists of a Scanner (E1000 Dx Digital Pathology Scanner), which generates in MRXS image file format, E1000 Dx Scanner Software, Image Management System (E1000 Dx IMS), E1000 Dx Viewer Software, and Display (Barco MDPC-8127). The Epredia E1000 Dx Digital Pathology Solution is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using Epredia E1000 Dx Digital Pathology Solution.

The E1000 Dx Digital Pathology Solution is a high-capacity, automated whole slide imaging system for the creation, viewing, and management of digital images of surgical pathology slides. It allows whole slide digital images to be viewed on a display monitor that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The E1000 Dx Digital Pathology Solution consists of the following three components: Scanner component: - . E1000 Dx Digital Pathology Scanner with E1000 firmware version 2.0.3 - . E1000 Dx Scanner Software version 2.0.3 Viewer component: - E1000 Dx Image Management System (IMS) Server version 2.3.2 ● - . E1000 Dx Viewer Software version 2.7.2 Display component: - . Barco MDPC-8127 The E1000 Dx Digital Pathology Solution automatically creates digital whole slide images by scanning formalin-fixed, paraffin-embedded (FFPE) tissue slides, with a capacity to process up to 1,000 slides. The E1000 Dx Scanner Software (EDSS), which runs on the scanner workstation, controls the operation of the E1000 Dx Digital Pathology Scanner. The scanner workstation, provided with the E1000 Dx Digital Pathology Solution, includes a PC, monitor, kevboard, and mouse. The solution uses a proprietary MRXS format to store and transmit images between the E1000 Dx Digital Pathology Scanner and the E1000 Dx Image Management System (IMS). The E1000 Dx IMS is a software component intended for use with the Barco MDPC-8127 display monitor and runs on a separate, customer-provided pathologist viewing workstation PC. The E1000 Dx Viewer, an application managed through the E1000 Dx IMS, allows the obtained digital whole slide images to be annotated, stored, accessed, and examined on Barco MDPC-8127 video display monitor. This functionality aids pathologists in interpreting digital images as an alternative to conventional brightfield microscopy.

For In Vitro Diagnostic Use FullFocus is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended to be used with the interoperable components specified in the below Table. Table: Interoperable components of FullFocus | Scanner Hardware | Scanner Output file format | Interoperable Displays | |-------------------------------------------|----------------------------|------------------------------------------| | Leica Aperio GT 450 DX scanner | DICOM, SVS | Dell UP3017<br>Dell U3023E | | Hamamatsu NanoZoomer S360MD Slide Scanner | NDPI | Dell U3223QE<br>JVC-Kenwood JD-C240BN01A |

FullFocus, version 2.29, is a web-based software-only device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from FDA cleared digital pathology scanners on FDA cleared displays. FullFocus renders these digitized pathology images for review, management and navigation for pathology primary diagnosis. Image acquisition is performed using the intended scanner (s), with the operator conducting quality control on the digital WSI images according to the scanner's instructions for use and lab specifications to determine if re-scans are needed. Please see the Intended Use section and below tables for specifics on scanners and respective displays for clinical use. Once a whole slide image is acquired using the intended scanner and becomes available in the scanner's database file system, a separate medical image communications software (not part of the device), automatically uploads the image and corresponding metadata to persistent cloud storage. Integrity checks are performed during the upload to ensure data accuracy. The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis. FullFocus operates with and is validated for use with the FDA cleared components specified in the tables below: | Scanner Hardware | Scanner Output file format | Interoperable Displays | |-------------------------------------------|----------------------------|------------------------------------------| | Leica Aperio GT 450 DX scanner | DICOM, SVS | Dell UP3017<br>Dell U3023E | | Hamamatsu NanoZoomer S360MD Slide Scanner | NDPI | Dell U3223QE<br>JVC-Kenwood JD-C240BN01A | Table 1: Interoperable Components Intended for Use with FullFocus FullFocus version 2.29 was not validated for the use with images generated with Philips Ultra Fast Scanner. Table 2: Computer Environment/System Requirements for during the use of FullFocus | Environment | Component | Minimum Requirements | |-------------|------------------|-----------------------------------------------------------------------------------------| | Hardware | Processor | 1 CPU, 2 cores, 1.6GHz | | | Memory | 4 GB RAM | | | Network | Bandwidth of 10Mbps | | Software | Operating System | • Windows<br>• macOS | | | Browser | • Google Chrome (129.0.6668.90 or higher)<br>• Microsoft Edge (129.0.2792.79 or higher) |

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. They are an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. The displays are not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

The C811WT. PA27T. C811W. PA27 are 8MP Color LCD Displays, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners that have been validated for use with the display. The displays are equipped with a 27-inch color LCD panel with a fine pixel pitch. They use the latest generation of LED backlight panels. The built-in brightness stabilization control circuits make sure the brightness of these displays is stable in their life, so the products meet the demands of high precision medical imaging. For C811WT. PA27T. C811W. PA27. the only difference is the capacitive touch screen. C811WT, PA27T have the same capacitive touch screen. C811W, PA27 don't have a capacitive touch screen. The difference between C811WT and PA27T is only different customers which results in the two models. The difference between C811W and PA27 is only different customers which results in the two models.

Roche Digital Pathology Dx is an automated digital slide creation, viewing and management system. Roche Digital Pathology Dx is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. Roche Digital Pathology Dx is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. Roche Digital Pathology Dx is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. Roche Digital Pathology Dx is composed of VENTANA DP 200 slide scanner, VENTANA DP 600 slide scanner, Roche uPath enterprise software, and ASUS PA248QV display. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using Roche Digital Pathology Dx.

Roche Digital Pathology Dx (hereinafter referred to as RDPD), is a whole slide imaging (WSI) system. It is an automated digital slide creation, viewing, and management system intended to aid pathologists in generating, reviewing, and interpreting digital images of surgical pathology slides that would otherwise be appropriate for manual visualization by conventional light microscopy. RDPD system is composed of the following components: - · VENTANA DP 200 slide scanner, - · VENTANA DP 600 slide scanner, - · Roche uPath enterprise software, and - · ASUS PA248QV display. VENTANA DP 600 slide scanner has a total capacity of 240 slides through 40 trays with 6 slides each. The VENTANA DP 600 slide scanner and VENTANA DP 200 slide scanner use the same Image Acquisition Unit. Both VENTANA DP 200 and DP 600 slide scanners are bright-field digital pathology scanners that accommodate loading and scanning of 6 and 240 standard glass microscope slides, respectively. The scanners each have a high-numerical aperture Plan Apochromat 20x objective and are capable of scanning at both 20x and 40x magnifications. The scanners feature automatic detection of the tissue specimen on the glass slide, automated 1D and 2D barcode reading, and selectable volume scanning (3 to 15 focus layers). The International Color Consortium (ICC) color profile is embedded in each scanned slide image for color management. The scanned slide images are generated in a proprietary file format, Biolmagene Image File (BIF), that can be uploaded to the uPath Image Management System (IMS), provided with the Roche uPath enterprise software. Roche uPath enterprise software (uPath), a component of Roche Digital Pathology Dx system, is a web-based image management and workflow software application. uPath enterprise software can be accessed on a Windows workstation using the Google Chrome or Microsoft Edge web browser. The user interface of uPath software enables laboratories to manage their workflow from the time the whole slide image is produced and acquired by VENTANA DP 200 and/or DP 600 slide scanners through the subsequent processes, such as review of the digital image on the monitor screen and reporting of results. The uPath software incorporates specific functions for pathologists, laboratory histology staff, workflow coordinators, and laboratory administrators.